512.494.9949
Larry F., Former Client
"I'm not sure where I would be today if it weren't for Justin and the law firm he is with... You become a part of the family the day you become a client and there is nothing more satisfying... If you want the best, the most terrific, then this is the man you want as your attorney."
Ben C., Former Client
"They're good people, plain and simple. I had the opportunity to work with Justin Demerath on a few issues. One where he had nothing to gain financially and the other, he did. There was no difference in his demeanor, the way he treated me or his intent. He just wanted to help in any way he could."
Herbert F., Former Client
"I want to thank you Justin for a job well done. My case was certainly a difficult one as attested to by the number of rejections I had before your name was given to me... You were up front about my chances for a win, never denying the road blocks that certainly would arise. I was impressed by the professional manner in which you handled my case."
Melanie S., Former Client
"The service I received from Justin Demerath has been unparalleled in every aspect. He is very professional, concise, and empathic towards his clients. My settlement exceeded my expectations on my collarbone injury case, in result of his strong desire for success."
Teresa P., Former Client
"WOW! I haven't seen this kind of customer service in years. Justin visited with me on the phone until all my questions were answered. He was extremely helpful, gracious, pleasant, willing, professional and very nice."
"In the midst of dealing with insurance, body shop, doctors and staff all of whom were 'just doing their job'... Justin was a ray of sunshine on a very gloomy day in my life. He made me feel very comfortable and encouraged me to continue with my questions... Thank you Justin...God bless you."
Jon S., Former Client
"Fantastic Representation. Justin Demerath represented me in a motorcycle accident where I was injured severely. The outcome was a best case scenario based on the realities of the at-fault driver. I received the largest settlement that was available and it turned out well. That was the bottom line, but what I wanted to comment on was Justin's willingness to explain each step of the process and his personal interest in my case. He came to visit me at my house while I was still unable to walk and his competence and ability to put things in simple terms allowed me to feel comfortable to take the details of my case off my plate and put it in his hands."
Nancy C., Former Client
"I am just so impressed in your scientific and legal knowledge. Your commitment and enthusiasm goes beyond compare. Should I ever need your services again or if someone I know needs your expertise, I will not hesitate to give you and call or make a referral."
Jay B., Former Client
"My experience with the insurance companies over the 15 months following the accident was frustrating... I admit I was also reluctant to find a personal injury lawyer, based on the stereotype of personal injury lawyers that I had ... I no longer carry that stereotype with me, I've since learned better."
Cindy R., Former Client
"Great Representation. I was involved in an auto accident two years ago and, after unsatisfactory dealings with the insurance company of the other driver, I hired Justin Demerath to represent me in my claim for medical bills coverage.... Mr. Demerath is a true professional whose compassion for his clients and for the law is first rate."
Motorcycle Accident / Product Liability
| Gross Recovery: | $2,275,000.00 |
|---|---|
| Client Net: | $1,285,861 |
| Attorney Fees: | $910,000 |
| Expenses: | $79,138.18 |
| Medical Bills: | In excess of $170,438.09 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Product Liability
| Gross Recovery: | $2,025,000.00 |
|---|---|
| Client Net: | $810,153.07 |
| Attorney Fees: | $810,000.00 |
| Expenses: | $58,831.93 |
| Medical Bills: | In excess of $640,000.00 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Auto Accident
| Gross Recovery: | $1,850,000.00 |
|---|---|
| Client Gross: | $1,025,107.50 |
| Client Net: | $690,651.27 |
| Attorney Fees: | $671,000.00 |
| Expenses: | $152,430.75 |
| Medical Bills: | In excess of $339,982.00 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Auto Accident
| Gross Recovery: | $1,250,000.00 |
|---|---|
| Client Net: | $671,000 |
| Attorney Fees: | $500,000 |
| Expenses: | $17,000 |
| Medical Bills: | $62,000 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Apartment Fire - Negligent Design of an Apartment Complex
| Gross Recovery: | $950,000.00 |
|---|---|
| Client Net: | $288,300.20 |
| Attorney Fees: | $378,300.20 |
| Expenses: | $251,730.48 |
| Medical Bills: | In excess of $532,393.34 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Negligence - 18-Wheeler Accident
| Gross Recovery: | $900,051.64 |
|---|---|
| Client Net: | $540,305.24 |
| Attorney Fees: | $279,000.00 |
| Expenses: | $65,619.78 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Product Liability / Defective Machinery
| Gross Recovery: | $785,000.00 |
|---|---|
| Client Net: | $494,488 |
| Attorney Fees: | $250,537 |
| Expenses: | $39,975.45 |
| Medical Bills: | In excess of $67,431.47 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Auto Accident
| Gross Recovery: | $600,000.00 |
|---|---|
| Client Net: | $330,643.88 |
| Attorney Fees: | $240,000.00 |
| Expenses: | $4,501.59 |
| Medical Bills: | In excess of $101,045.83 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Bus Accident
| Gross Recovery: | $410,000.00 |
|---|---|
| Client Net: | $240,693.11 |
| Attorney Fees: | $164,000.00 |
| Expenses: | $5,309.89 |
| Medical Bills: | In excess of $97,892.23 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Auto Accident
| Gross Recovery: | $152,500.00 |
|---|---|
| Client Net: | $84,609.24 |
| Attorney Fees: | $50,325.00 |
| Expenses: | $892.93 |
| Medical Bills: | In excess of $67,119.28 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Product Liability / Defective Design
| Gross Recovery: | $150,000.00 |
|---|---|
| Client Net: | $94,151.42 |
| Attorney Fees: | $49,500.00 |
| Expenses: | $6,348.58 |
| Medical Bills: | In excess of $47,704.60 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Auto Accident - Intoxicated Driver
| Gross Recovery: | $25,000.00 |
|---|---|
| Client Net: | $16,072.18 |
| Attorney Fees: | $8,332.50 |
| Expenses: | $595.32 |
| Medical Bills: | In excess of $17,892.00 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Auto Accident
| Gross Recovery: | $20,000.00 |
|---|---|
| Client Net: | $12,954.73 |
| Attorney Fees: | $6,660.00 |
| Expenses: | $385.27 |
| Medical Bills: | $31,018.92 |
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.
Skillful and Aggressive Legal Representation
When you or a loved one has endured personal injury or wrongful death, you have the right to seek justice and compensation. O'Hanlon, McCollom & Demerath is committed to providing each and every one of our clients with compassionate advocacy and skillful, tireless, aggressive representation. Our number one priority is providing each client with the most desirable legal outcome to every issue they are facing.
We Value and Respect Every Client
We believe that every client deserves and should receive one-on-one access and attention. Legal issues can be daunting without the protection of knowledgeable and experienced lawyers. O'Hanlon, McCollom & Demerath is dedicated to resolving your unique situation with compassion and diligence.
Superior Client Services
At O'Hanlon, McCollom & Demerath we ensure seamlessly integrated work product and representation through our utilization of state of the art technology and resources. We are committed to providing our clients superior legal representation at every turn.
Commitment to Getting you the Compensation you Deserve
In our efforts to obtain compensation for our clients who have suffered injuries and the related indignities arising from the negligent actions of individuals and corporations, we pledge to provide you with a personalized, "no stone unturned" pursuit in achieving the most favorable outcome on your behalf in what are, undoubtedly, the most important and often life-changing situations you may ever experience.
Our clients never owe any fees unless we obtain financial settlement on their behalf. We will go the distance for you.
Contact Our Personal Injury Attorneys Today
O'Hanlon, McCollom & Demerath offers you a free one-on-one evaluation of your personal injury case. Our clients never pay for our legal services unless we obtain a successful recovery of compensation for you. Contact us today for a free and confidential consultation with our experienced personal injury lawyers.
Kevin O'Hanlon
Kevin O'Hanlon, the founding partner of O'Hanlon, McCollom & Demerath began practicing law in 1974 and has vast knowledge of all areas of litigation. Mr. O'Hanlon became Board Certified in Civil Appellate Law by the Texas Board of Legal Specialization in 1987, and in Civil Trial Law in 1990.
Justin Demerath
Justin Demerath joined the firm as a law clerk during his final year of law school and has been with the firm since that day. He has dedicated his law practice to helping people who have suffered damages at the hands of others in the state of Texas recover monetary compensation. Mr. Demerath has one mission in his work: to fight for the rights of the clients he represents.
Benjamin Castillo
In 2010, Mr. Castillo graduated from The University of Texas at Austin with a Bachelor of Arts in Government. Upon graduation, Mr. Castillo worked as a government and history teacher in the Rio Grande Valley.
Nick Maddox
Nick Maddox is an associate attorney who represents clients in a diverse range of litigation issues. Licensed to practice in both State court and Federal court, Mr. Maddox handles injury, employment, business, and contract disputes.
Amalia Hanley
Ms. Hanley graduated with honors from the University of Notre Dame with Bachelors of Arts degrees in History and Art History. In 1998, Ms. Hanley graduated with honors from the University of Florida School of Law. During school, and continuing after graduation, Ms. Hanley clerked for the Public Defender's Office in Gainesville, Florida, gaining criminal litigation experience in the Misdemeanor Division.
Alice Ward
Alice Ward was born in Ithaca, NY and raised in Jersey City, NJ. The older of two daughters, she graduated from Friends Seminary, a Quaker high school, in 1996. Ms. Ward attended the University of Texas in Austin, attaining a BA in History in 2000. She also became a certified paralegal through Austin Community College.
Adelie Alvarez
Adelie Alvarez grew up in Buda Texas and graduated from Hays High School. She has extensive experience in many areas of law. Since 2006, Adelie has worked for various local Austin attorneys.
Serious Personal Injury
Every year, hundreds of Texans suffer serious injury because of the reckless actions of another. If you were hurt in a car accident or pedestrian accident, or a loved one was injured using a defective product, the personal injury attorneys at O'Hanlon, McCollom & Demerath are here to help.
Wrongful Death
It is unfortunate, but it is usually up to the victim's family to pursue a wrongful death claim after the accidental death of a loved one. At a time when you feel most vulnerable and emotionally exhausted, a lawsuit is the last thing on your mind. But it's important to give it some consideration. An experienced, dedicated Austin injury attorney can help.
Car Accidents
Car accidents carry serious physical and financial consequences. Injuries can leave you unable to work and prevent you from enjoying a normal life. To make matters worse, your insurance company may more committed to its bottom line than your recovery. At O'Hanlon, McCollom & Demerath in Austin, Texas, our main priority, is representing people who have been injured in car accidents and make them whole again.
Motorcycle Accidents
With the freedom and excitement motorcycle riders enjoy comes the risk of serious injury in an accident. Despite the consistent warnings drivers receive to “start seeing motorcycles,” thousands of people across Texas are injured in motorcycle accidents. If you have been involved in an accident, you can benefit from immediate representation from an experienced motorcycle accident lawyer .
Truck Accidents
Collisions between commercial trucks and cars or passenger trucks almost always result in life-changing injuries or tragic deaths. Because of the seriousness of these accidents, it's important to work with an experienced Austin personal injury attorney who will protect your rights.
Product Liability
Whether you buy something from a big-box retailer, midsize market, outlet store, mall, or small grocer, you expect the product to be safe. However, sometimes you may buy a product that injures you, and product liability and defective product law dictates who is responsible for this breach of the implied warranty of fitness for the product’s intended uses. The place from where you purchased the product, the company that made the product, or even the company that advertised the product may be legally held responsible for your injury.
Defective Drugs
The defective drug product liability attorneys at O'Hanlon, McCollom & Demerath law firm understand that your injuries and complications may be the result of a defective drug. We are here to help you get the compensation you deserve for your injuries.
Defective Medical Devices
The defective medical device liability attorneys at O'Hanlon, McCollom & Demerath law firm understand that your injuries and complications may be the result of a defective medical device. We are here to help you get the compensation you deserve for your injuries.
Business Litigation
Disputes are an unfortunate, and often expensive, part of doing business. At O'Hanlon, McCollom & Demerath in Austin, Texas, our business litigation attorneys are experienced professionals who can protect your interests if you are embroiled in a legal dispute.
Fatal Auto Accidents
Car accidents are the leading cause of accidental death, bringing pain and grief to hundreds of Texas families every year. If a loved one has died in a fatal car accident, an SUV rollover, a collision with a commercial truck, or a motorcycle crash, you will be facing financial challenges, and we are here to solve your problems.
Defective Machinery / Equipment
Heavy equipment and workplace machinery can be dangerous even when it’s used properly. But when that equipment is faulty, has defective parts, or has been improperly repaired or serviced, even careful users can suffer serious injury or death. The injury lawyers at O'Hanlon, McCollom & Demerath hold companies responsible for negligence in the manufacturing and maintenance of equipment and machinery that leads to injuries and deaths.
Pedestrian Accidents
Bike riders and cycling enthusiasts bear an unfair burden when car and truck drivers do not drive carefully. With so little protection beyond a bike helmet and their quick reflexes, cyclists often suffer severe injuries when a car makes a sudden stop or a truck turns into their path. Sadly, many bicycle accident victims are children. If you have been seriously injured or a loved one has died in a bicycle collision with a motor vehicle or a cycling accident on a dangerous property, you may have a right to financial compensation.
How do I choose the right attorney for my case?
When you or a loved one has suffered an injury, hiring an attorney is one of the most important steps you will take toward seeking compensation from those who are responsible for your injuries. This can be a daunting and complicated process if you have never before hired an attorney and do not know how it all works.
What are my rights as a client?
If you ever have any questions about these rights, or about the way your case is being handled by your attorney, do not hesitate to express your concerns to your attorney. He or she should be readily available to represent your best interests and keep you informed about your case.
What should I do immediately after an accident?
Just after an accident or other event which seriously injures your or a loved one you may not know what to do or where to turn for help, especially when you have been injured by the negligence or wrongdoing of another person, or in many instances, the manufacturer of defective equipment or other products.
What is the Personal Injury Lawsuit Process?
After an accident in which you or a loved one are injured, and you have sought medical attention and have hired an attorney to handle your insurance claim, you may be on your way to becoming a plaintiff in a personal injury lawsuit if the insurance company has refused to make a reasonable offer of settlement on your injury claim.
Could ERISA reduce my claim recovery?
The Employee Retirement Income Security Act of 1974, known as "ERISA", is a federal law that may allow your insurance company, or your employer's health plan, to recover its costs on your claim, from a settlement or trial verdict award you may receive as a result of a personal injury lawsuit. This is known as "subrogation", and is considered to be a complex area of law. Potential subrogation interests should be discussed with your personal injury attorney after his/her review of any subrogation clauses in your insurance policy or your employer's health plan provisions.
What information will my attorney need from me?
When you or a loved one have been injured in any type of accident it is important to keep extensive documentation of the incident and your injuries. Your personal injury attorney will interact with insurance companies and defense attorneys on your behalf, and in order to make a proper claim for all the benefits you are entitled to, this documentation is necessary.
Some of our Victories
Product Liability Victory
Our firm represented a golf course grounds keeper who, due to a mechanical design defect in the industrial mower he was operating, was crushed under the machine when it fell into 15 foot ravine. The client suffered partial blindness, memory loss, and permanent brain damage.
Widow Prevails in Wrongful Death Action
Justin Demerath, in joint representation with his father, Attorney Larry Demerath, represented the widow of a truck driver who was killed when his vehicle struck a large tire that had detached from another truck. Larry and Justin are pictured above with the client.
Successful Settlement
Our firm represented a family in a wrongful death action against a large trucking company when their father was struck and killed by an 18-Wheeler due to a defective brake pedal. The case settled prior to trial. The brothers are pictured above.
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Our Practice Areas
Serious Personal Injury
Wrongful Death
Car Accidents
Motorcycle Accidents
Truck Accidents
Product Liability
Defective Drugs
Defective Medical Devices
Business Litigation
Fatal Auto Accidents
Defective Machinery / Equipment
Pedestrian Accidents
Automotive Product Liability
Sexual Assault / Abuse
Train,Plane,Bus,Cruise Accidents
Boating and Jet Ski Accidents
ATV Accidents
Bicycle Accidents
Catastrophic Injury
Spinal Cord Injury
Trasylol 60 Minutes Report
(CBS) This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.
As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.
But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.
How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month.
Doctors believe one of those patients was Joe Randone. He had a heart murmur since he was born, but that didn't keep him from an active life. On New Year's Eve 2005, Randone seemed to be the picture of health.
Two weeks later, Randone checked himself into a Long Island hospital for heart valve replacement surgery. He was 52, and the surgeon told his wife Josephine and daughter Marissa that the risks were low.
"They said even possibly in five days he would go home. And then, you know, there was a recovery period, as there would be with any kind of heart surgery," Josephine remembers.
"But then he should be in ICU for about 24 hours, and then move up to a regular floor, recuperate and come home," Marissa adds.
Asked if the doctors weren't particularly concerned about this, Josephine says, "No."
"It was routine as far as they were concerned," Marissa tells Pelley.
The surgeon noted the chance of complications at five percent. Trasylol was put in Joe's IV and kept flowing for four hours. At the end of the surgery, the Randones were told that something was wrong.
"They didn't go into specifics," Marissa says. "Just that there were a lot of complications, and that making it through the night was basically our first concern."
Immediately after the surgery, Randone suffered two heart attacks and his kidneys failed. Randone's surgeon wrote in his notes "Aprotinin-induced graft thrombosis." Aprotinin is Trasylol, and thrombosis means blood clotting.
At the same time, in San Francisco, an eminent medical researcher, Dr. Dennis Mangano, was finishing a study that had followed thousands of patients - the largest Trasylol study ever conducted.
Mangano says the study included 5,065 patients in 17 countries.
"It showed an important association between Trasylol use and kidney failure requiring dialysis, Mangano tells Pelley, "And it showed a trend toward increased death in hospital in these patients."
Dr. Mangano was one of the researchers who discovered that aspirin reduces the risk of heart attack. His non-profit institute studies drug safety and how generic drugs can lower health care costs. His work is credited with improving the health of millions. Ten days after Joe Randone's surgery, Mangano's study was published in the New England Journal of Medicine and reported in newspapers across the country, including Long Island.
Marissa says the doctor had just seen an article about the study in the newspaper. "The surgeon told us that he felt that the drug was the reason for all the complications," Marissa says.
"And that he had filed a report with the FDA, and he wanted us to be aware that it was because of this drug," she says.
What the surgeon likely didn't know was that there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. He told Bayer, but he was surprised by the drug company's reaction.
"I felt that Bayer wasn't interested to examine these side effects," Fischer says.
Soon, the same side effects were being seen in humans in America.
"The most common problem we saw was renal failure. That is, that kidneys did not function properly after surgery," says the Missouri Baptist Medical Center's Dr. Nicholas Kouchoukos, one of this country's top heart surgeons.
In 1992, he conducted a small study, not funded by Bayer, in which Trasylol was given to 20 patients.
"Thirteen of these patients had problems with kidney function after the procedure," Kouchoukos says.
"What did you think?" Pelley asks.
"Well, this was the red flag. And it appeared that it was related to the use of Trasylol," he says.
The red flags showed up in some studies, but not others. Safety concerns are often hard to assess until thousands of patients have received a drug. And critics maintain that Bayer never paid for any studies that were large enough to determining whether kidney failure was a problem. All the research did show Trasylol controlled bleeding, so in 1993, the FDA approved it.
"Doesn't a drug have to be proven safe before the FDA allows it on the market?" Pelley asks Mangano.
"No," he replies. "The trials that are constructed before a drug is marketed and given approval to be marketed generally address effectiveness of the studies."
"Make sure I understand. If the FDA is not certifying a drug as safe, before it goes on the market, what is it doing?" Pelley asks.
"It's certifying that the drug is effective and that within the small numbers studied, relatively small, it doesn't appear to be unsafe," Mangano says.
The FDA approved Trasylol for patients at high risk of bleeding and it noted kidney toxicity was a problem. Bayer pushed the drug hard. In 1998, the FDA expanded its approval to cover all heart bypass patients. By 2005, sales of the drug hit $300 million. The next year, $750 million was projected, and Bayer envisioned a billion-dollar drug.
Then came the Mangano study in 2006 that suggested thousands of patients had died. The FDA issued an advisory to doctors alerting them to Mangano's study. But the FDA didn't plan to have a meeting about Trasylol for eight months.
Bayer wanted to have its own study for that meeting to compare with Mangano's, so the company hired Harvard professor Dr. Alexander Walker to look at the records of nearly 70,000 patients. Walker's results were the much the same as Mangano's. Patients on Trasylol, he wrote, had an elevated risk of death and acute renal (kidney) failure.
Meanwhile on Long Island, winter turned to spring, and Joe Randone grew worse.
"It was a domino effect. Once the kidneys stopped working, then it affected other organs. He was so swollen that he couldn't even close his eyes," Josephine remembers.
Joe Randone's eyes were sewn shut to protect his corneas, and his gall bladder was removed. Because of poor circulation, his legs were amputated. Over eight months, he had 19 operations.
"They were amazed how he could rebound from all of these instances. They said, 'Anyone else who wasn't in good health, who didn't have such a strong will, would not have made it that far,'" Josephine says.
His tragedy is all the worse because there were two other drugs that might have been used in Randone's case without the consequences - drugs that cost $50, while Trasylol costs over $1,000.
"They were as effective in our studies as Trasylol in limiting bleeding, and limiting the amount of blood transfused," Mangano says. "With none of the adverse side effects."
In 2006, Mangano presented his study to the FDA's advisory committee; cardiologist Dr. William Hiatt chairs that committee and ran the meeting.
Asked what Mangano was asking the committee to do, Dr. Hiatt tells Pelley, "He was asking us to review his observational data and he clearly stated that he felt this drug carried significant risk. And he was asking the committee to review that risk. And then perhaps recommend to the FDA the drug should be not used anymore."
Mangano's study was not embraced wholeheartedly by the committee because it was not the gold standard in medicine: a clinically controlled experiment testing Trasylol against a placebo. Rather, Dr. Mangano's study looked at hospital records to see how patients did in the real world.
By the time of the meeting, Bayer was holding the results of the study that it had commissioned from Alexander Walker at Harvard. But Bayer representatives stood before the committee and did not reveal that their study existed.
"The representatives at the meeting who were senior, responsible, should have disclosed fully to the FDA that a study was done, that data were being accumulated and even put the meeting in abeyance until the data were found or discussed. And that was not done," Mangano says.
"Good medicine demands that you protect the patient. That's the issue here, and not the drug, and not the profit margin," he says.
Why would Bayer withhold this information from Hiatt's committee?
"They claim that the data wasn't ready for review," Hiatt says. "There were lots of reasons that they claimed. But again, I can't speculate. The reality is we didn't have the data."
"They weren't being honest with you?" Pelley asks.
"I can't draw that conclusion. I just know that they didn't provide data that was there," Hiatt says.
Hiatt's FDA committee - in the dark about the Bayer study that confirmed Mangano's results - voted to keep Trasylol on the market. The next week, Alexander Walker, the author of the Bayer research, went to the FDA to blow the whistle on Bayer for failing to present his study.
The FDA reacted by issuing another warning to doctors. But a year would go by before the advisory committee would meet again to consider the results of Bayer's hidden study, a meeting Dr. Hiatt did not attend.
Hiatt told 60 Minutes that if he had known about Bayer's study at the first meeting he would have voted to take Trasylol off the market. When he found out what had happened, he wrote an editorial that was published two months later.
"I wrote a perspective piece that disclosed to the American public there were concerns about transparency," he says.
"You describe them as concerns about transparency. Tell me how you felt. You had to be surprised," Pelley asks.
"I'm a scientist. I just review the data," Hiatt says. "How do I feel about this? I don't know."
Asked if he had been angry, Hiatt responds, "I thought it was unusual. I thought it was truly inappropriate."
Last year, the Canadian government conducted a large clinical trial of Trasylol. The study had to be stopped because patients in the study group were dying.
When the study was halted, Germany banned Trasylol, and the Canadians and the FDA persuaded Bayer to suspend marketing temporarily, though surgeons can still use it in special cases. Worldwide, more than four and a half million people had been given the drug. About a third of them were Americans who received it during the 14 years that it was on the U.S. market.
Mangano says the FDA should have pulled Trasylol after his study two years before.
"How many patients according to your analysis would have been saved if the drug had been taken off the market after your first study?" Pelley asks.
"Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market," he says.
To the Randones, one life mattered most. In August 2006, Joe Randone died. His family is suing Bayer, which expects to post record profits for this past year, partly on the strength of Trasylol.
Neither Bayer nor the FDA would speak with 60 Minutes for this story. Bayer did send a letter which said, in part, "the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling."
Bayer says it suspended two employees for failing to disclose the results of its 2006 study. But the FDA has taken no action against the drug maker.
